HealthyPhase 2NCT00563472
Feasibility Study Into the Contraceptive Effect of Estetrol
A Phase 2 study testing estetrol, estetrol and desogestrel and estetrol and progesterone in people with Healthy, run by Pantarhei Bioscience at 1 site in Netherlands.
Trial summary
This is an open study in 50 young, healthy, female volunteers. Women who want to participate and who are using hormonal contraception stop using their hormonal contraceptive and wait for their first spontaneous menstruation (i.e. after a wash-out cycle). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- estetrol, estetrol and desogestrel and estetrol and progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 18 years and not older than 40 years of age
- Willing to use a barrier method of contraception during the wash-out cycle, the pre-treatment cycle, the period of study drug administration, the period of lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up visit if this 14-days period ends before the follow-up visit.
- Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of their menses, who have a subsequent P concentration of > 16 nmol/l and whose next menstruation does not start within 6 days after ovulation
- Body Mass Index > 18 and <30 kg/m2
- Good physical and mental health
- Both ovaries visible upon ultrasonography
- Willing to give informed consent in writing
Who cannot join
- Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, and/or ECG in the opinion of the Investigator at screening.
- Known or suspected pregnancy
- Lactation
- Pregnancy during accurate hormonal contraceptive use
- Known or suspected breast cancer or a history of breast cancer
- Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound (non-physiological ovarian mass or significant uterine pathology).
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- A cervical smear with clinically relevant abnormal cytology within one year before study start.
- Previous use of depot progestogen preparations in the last 6 months.
- Contraindications for contraceptive steroids:
- a history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
- a history of, or existing conditions predisposing to, or being prodromi of, a thrombosis
- a known defect in the blood coagulation system (e.g. deficiencies in AT-III, protein C, S, and APC resistance)
- heterozygous for a mutation in coagulation factor II and/or positive for factor V Leiden
- the presence of a severe or more than one risk factor for vascular disease (e.g. dyslipoproteinaemia; diabetes mellitus; hyperhomocysteinaemia; systemic lupus erythematosus; chronic inflammatory bowel disease; antiphospholipid antibodies; smoking; venous thromboembolism in sibling or parent below the age of 50, or arterial disease in sibling or parent below the age of 35; within 2 weeks after full remobilisation following surgery)
- hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg
- disturbance of liver function: e.g. cholestatic jaundice, a history of jaundice of pregnancy or jaundice due to previous oestrogen use, Rotor syndrome and Dubin-Johnson syndrome
- known or suspected hormone-dependent tumours or endometrial hyperplasia
- undiagnosed vaginal bleeding
- porphyria
- a history during pregnancy or previous hormone-use of severe pruritus, herpes gestationis or deterioration of otosclerosis
- Use of one or more of the following medications:
- sex steroids other than the medication of study
- use at present or within 2 months before start study medication:
- hydantoins, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, troglitazone, felbamate, rifampicin, rifabutin, griseofulvin and St. John's wort (Hypericum perforatum)
- Status post-partum or post-abortion within a period of 2 months before study start
- Administration of investigational drugs within 3 months before start study medication
- A history of (within 12 months) alcohol or drug abuse
- A known hypersensitivity for one of the components of the study medication (eg arachisoil and lactosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Into the Contraceptive Effect of Estetrol Alone or Combined With Either Progesterone or Desogestrel by Daily Oral Administration to Healthy Female Volunteers for 28 Days.
This is an open study in 50 young, healthy, female volunteers. Women who want to participate and who are using hormonal contraception stop using their hormonal contraceptive and wait for their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use hormonal contraception wait for their next menstruation. From the 9th day after start of the menstruation onwards follicle growth will be monitored by ultrasonography until ovulation occurs or until day 24 after start of their menses. Women who ovulate within 24 days after start of their menses will be eligible to participate and will be stratified in one of 4 groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days. Treatment will start on the first day of their menses after the pre-treatment cycle.
During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO) axis will be investigated by measuring follicular development using ultrasonography and by determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), estradiol (E2) and Progesterone (P).
- Conditions
- Healthy
- Being tested
- estetrol, estetrol and desogestrel, estetrol and progesterone
- Keywords
- Healthy female volunteers will participate in this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estetrolDrug
10 mg orally per day for 28 days
estetrolDrug
20 mg orally per day for 28 days
estetrol and desogestrelDrug
20 mg estetrol and 150 microg desogestrel orally per day for 28 days
estetrol and progesteroneDrug
20 mg estetrol and 200 mg progesterone orally per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 10 mg estetrol Receives: Drug: estetrol |
| 2 | Active comparator | 20 mg estetrol Receives: Drug: estetrol |
| 3 | Active comparator | 20 mg estetrol and 150 microg desogestrel Receives: Drug: estetrol and desogestrel |
| 4 | Active comparator | 20 mg E4 and 200 mg progesterone Receives: Drug: estetrol and progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation inhibition
Measured: during treatment
Secondary outcomes (1)
endocrine parameters
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pantarhei Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- H. Coelingh Bennink, MD, PhD, Study director, Pantarhei Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563472
- Sponsor's protocol ID
- PR3081
- Status last verified
- May 2012
- First submitted
- 22 Nov 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Into the Contraceptive Effect of Estetrol Alone or Combined With Either Progesterone or Desogestrel by Daily Oral Administration to Healthy Female Volunteers for 28 Days.
- ClinicalTrials.gov ID
- NCT00563472
- Acronym / sponsor ID
- PR3081
- Conditions
- Healthy
- Keywords
- Healthy female volunteers will participate in this study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pantarhei BioscienceIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open study in 50 young, healthy, female volunteers. Women who want to participate and who are using hormonal contraception stop using their hormonal contraceptive and wait for their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use hormonal contraception wait for their next menstruation. From the 9th day after start of the menstruation onwards follicle growth will be monitored by ultrasonography until ovulation occurs or until day 24 after start of their menses. Women who ovulate within 24 days after start of their menses will be eligible to participate and will be stratified in one of 4 groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days. Treatment will start on the first day of their menses after the pre-treatment cycle.
During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO) axis will be investigated by measuring follicular development using ultrasonography and by determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), estradiol (E2) and Progesterone (P).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: estetrol10 mg estetrol |
| 2 | Active comparator | Drug: estetrol20 mg estetrol |
| 3 | Active comparator | Drug: estetrol and desogestrel20 mg estetrol and 150 microg desogestrel |
| 4 | Active comparator | Drug: estetrol and progesterone20 mg E4 and 200 mg progesterone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- At least 18 years and not older than 40 years of age
- Willing to use a barrier method of contraception during the wash-out cycle, the pre-treatment cycle, the period of study drug administration, the period of lynestrenol intake (if applicable), and 14 days thereafter or until the follow-up visit if this 14-days period ends before the follow-up visit.
- Women who ovulate in the pre-treatment cycle before or on day 24 (±1) after start of their menses, who have a subsequent P concentration of > 16 nmol/l and whose next menstruation does not start within 6 days after ovulation
- Body Mass Index > 18 and <30 kg/m2
- Good physical and mental health
Key exclusion criteria (28 listed)
- Clinically significant abnormal results of routine hematology, serum biochemistry, urinanalysis, and/or ECG in the opinion of the Investigator at screening.
- Known or suspected pregnancy
- Lactation
- Pregnancy during accurate hormonal contraceptive use
- Known or suspected breast cancer or a history of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estetrol10 mg orally per day for 28 days | Drug | 1 |
| estetrol20 mg orally per day for 28 days | Drug | 2 |
| estetrol and desogestrel20 mg estetrol and 150 microg desogestrel orally per day for 28 days | Drug | 3 |
| estetrol and progesterone20 mg estetrol and 200 mg progesterone orally per day for 28 days | Drug | 4 |
Primary outcome
ovulation inhibition
Time frame: during treatment
1 secondary outcome
endocrine parameters
Time frame: during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Coelingh Bennink, MD, PhD study director
Pantarhei Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing estetrol, estetrol and desogestrel and estetrol and progesterone in people with Healthy, run by Pantarhei Bioscience at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovulation inhibition (time frame: during treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.